Idorsia reacquires the world-wide rights to aprocitentan - Seite 2

Janssen funding obligations to aprocitentan cease at the effective date of the agreement. Janssen licenses to aprocitentan IP (excluding pulmonary hypertension) will terminate and Janssen will transfer the brand name and relating commercial materials to Idorsia. Janssen will retain licenses in the pulmonary hypertension field.

The agreement also eliminates the revenue-sharing agreement in respect of ponesimod.

The agreement will be effective following receipt of the clearance relating to the United States Hart-Scott Rodino Antitrust Improvements Act of 1976.

André C. Muller, Chief Financial Officer, commented:
“If aprocitentan is approved in the US and Europe as we expect, Idorsia would have an additional product in its portfolio giving the company more strategic flexibility, and potentially allows Janssen to recoup over time their investment in aprocitentan.”

About the regulatory status of aprocitentan
A new drug application (NDA) for aprocitentan was filed with the US FDA in December 2022 (Prescription Drug User Fee Act (PDUFA) current date: December 19, 2023), and the market authorisation application (MAA) was submitted to the EMA at the end of January 2023.

Jean-Paul Clozel, concluded:
“The review process with the US FDA is progressing well, though it is likely to require an extension to the review period of up to 3 months as the company will provide additional Risk Evaluation and Mitigation Strategy (REMS) materials to support a streamlined REMS which is designed specifically for patients taking aprocitentan.”

About aprocitentan in resistant hypertension
Full results from the PRECISION study were published in November 2022 in The Lancet “A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension”. More details and commentary can be found in the dedicated press release and an investor webcast featuring Prof. Markus Schlaich, an investigator in PRECISION.

Patients with uncontrolled blood pressure are at risk of major cardiovascular events.¹ These risks are even higher for patients whose blood pressure is uncontrolled despite treatment with three or more antihypertensives², known as resistant hypertension^3,4. It has been more than 30 years since a new anti-hypertensive therapy working by a new mechanism has been brought to patients. By targeting a currently unopposed pathophysiologic pathway, aprocitentan represents a potential novel, effective, and well-tolerated treatment for resistant hypertension.